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Process Systems Engineer

Job Location

Devens, MA

Workspace

Hybrid (50% minimum on-site)

Target Hiring Date

July 14, 2025

Work Authorization

Applicants must have the legal right to work in the United States without requiring sponsorship. Corp-to-Corp (C2C) arrangements are not accepted.

Requirements

EDUCATION:

+ Bachelor’s Degree required in Engineering or Related Discipline (advanced degree is preferred).

QUALIFICATIONS:

+ Minimum 2 years of manufacturing support or related experience in the biopharmaceutical industry.

+ Experience in cell therapy/biologic/vaccine manufacturing support, tech transfer, and validation .

+ Design and execute test plans and other risk mitigation exercise as part of investigations (e.g. Root cause analysis and CAPAs).

+ Experience in GMP setting and CAR-T cell therapy.

+ Sponsor and support the change initiatives and the implementation of process improvement initiatives .

+ Support Clinical Production Activities.

+ Experience with the start-up, validation, and licensure of new biopharmaceutical manufacturing facilities.

+ Basic knowledge of cGMP’s and multi-national biopharmaceutical/cell therapy regulations.

+ Basic knowledge of facility/clean room design, process, equipment, automation, and validation.

+ Intermediate strong verbal/written communication skills and ability to influence at all levels.

+ Intermediate ability to think strategically and to translate strategy into actions.

+ Intermediate ability to prioritize and provide clear direction to team members in a highly dynamic environment.

+ Basic knowledge of quality by design and risk management.

+ Basic experience with Operational Excellence and Lean Manufacturing

About the Role

JOB DESCRIPTION:

The Process Systems Engineer provides input to the design and development for electronic Process systems including electronic batch records (MES), DeltaV, OSI Pi, and process monitoring systems. The Engineer works with Digital Plant, IT, Manufacturing Operations, and process subject matter experts to deliver process Changes. The position requires excellent project management skills and coordination with stakeholders, as well as leadership, enthusiasm, intellectual curiosity, scientific rigor, and a desire to help drive novel programs. The candidate must be goal-oriented, flexible, and a subject matter expert in process systems.

DUTIES AND RESPONSIBILITIES:

• Apply manufacturing process expertise and process system technical knowledge during change management.

• Own User Requirements for process systems. Ensure consistent execution of system modifications and changes. Ensure adherence with governing documents related to change management.

• Works collaboratively with Manufacturing, Digital Plant, IT, Validation, Quality, and MSAT to ensure change initiatives are driven to closure and migrated to the production area in a timely manner.

• Owns the lifecycle of process system changes.

• Works with site functional teams, including manufacturing, engineering, warehouse, and quality assurance to gather user requirements for change development.

• Understanding of DeltaV and MES library objects. Use that understanding to direct changes to associated systems.

• Develop documentation to support the qualification of the DeltaV and MES recipes, including test scripts and User Requirements.

• Execute testing of the changes in the development environment to ensure functionality.

• Support Chain of Identity program and ensure it is maintained within the process systems.

• Manage User Acceptance Testing process for system qualification.

• Develop and deliver reports from reporting software.

• Provide technical support for manufacturing operations, investigations and change controls as a process system subject matter expert.

About the Company

Join Sokol GxP Services – Where Innovation Meets Integrity!

Join Sokol GxP Services, where we partner with leading pharmaceutical and biotech companies to provide exceptional Commissioning, Qualification, and Validation (CQV) services. We are committed to fostering diversity, empowering local talent, and building strong community connections to bring the best-qualified candidates to our clients in the Summit, NJ area. Our inclusive and collaborative culture promotes growth and innovation.

Let’s shape the future of life sciences together!

Our benefits:

• health insurance,

• 401(k),

• paid holidays,

• UTO.

All applicants will receive an acknowledgement that their application has been received within 2-3 weeks from the from the date of receipt.

Equal Opportunity Employer Statement:

Sokol GxP Services is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

By submitting your application and resume, you consent to have your information retained in our repository for six months. This allows us to consider you for future opportunities that may align more closely with your skills and qualifications. If a suitable position becomes available, we will contact you directly.